Research & Related Other Project Information 6. Project Abstract: There is an urgent need for biomarkers to diagnosis lupus (systemic lupus Erythematosus; SLE) and to monitor activity of the disease. Lupus, the prototype of systemic autoimmune diseases, primarily affects young women. A major consequence of the lack of lupus biomarkers is reluctance of the pharmaceutical industry to invest in development and evaluation of new lupus therapies. A new drug for lupus has not been approved by the Food and Drug Administration (FDA) in over 40 years. The FDA and the NIH have recently begun to collaborate in an effort to accelerate discovery and validation of lupus biomarkers. 1 outcome of this collaboration has been establishment of the NIH Biomarker Working Group. This group recently identified and published a list of the most promising lupus biomarkers. Among these candidates was a technology platform recently discovered by Drs. Susan Manzi and Joseph Ahearn at the University of Pittsburgh School of Medicine. This platform, cell-bound complement activation products (CB-CAPs), is currently protected by 5 patent applications filed by the University of Pittsburgh. StageMark, Inc. was founded in 2004 and granted an exclusive license to the CB-CAP technology in 2005. The CB-CAP technology platform currently consists of a panel of numerous assays to detect complement receptors and protein ligands generated by complement activation and deposited on surfaces of circulating cells such as erythrocytes, platelets, and lymphocytes. Preliminary studies have demonstrated that individual CB-CAP assays are more sensitive and specific for lupus diagnosis and monitoring than are gold standard tests such as serum C3 and C4 and anti-dsDNA currently used in clinical practice. The long-term goal of this proposal is to identify distinct CB-CAP panels (assay combinations) for lupus diagnosis and monitoring respectively, with the highest sensitivity and specificity and to foster market adoption of these biomarkers tests for routine clinical practice and for evaluation of new therapies by the pharmaceutical industry. There are 2 specific aims of this phase I SBIR application. The first aim is to identify each of 2 CB-CAP panels with optimal sensitivity and specificity for lupus diagnosis and monitoring, respectively. The second aim is to standardize CB-CAP technology according to Good Laboratory Practice (GLP) quality control standards. Successful completion of these aims within a 6-month timeline will facilitate a multicenter CB-CAP clinical trial that will be the focus of a subsequent Phase II application. Research & Related Other Project Information 7. Project Narrative: SLE is a complex autoimmune disease that is difficult to diagnose and treat, and currently affects about 1.5 million Americans. The lack of available blood tests which can reliably diagnose lupus and monitor disease activity has been a major factor impeding new drug development; in fact, no new drug has been approved by the Food and Drug Administration for the treatment of lupus in more than 40 years. The studies proposed in this application are intended to bring promising new biomarker blood tests for lupus diagnosis and disease monitoring from the basic research laboratory to patients, practicing physicians, and the pharmaceutical industry. [unreadable] [unreadable]